GOG-3025 DUO-O (Ovarian or Fallopian tube Cancer) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn about the safety and effectiveness of the drugs durvalumab with or without olaparib when they are added to standard of care chemotherapy and bevacizumab.
What is the Condition Being Studied?
Newly diagnosed advanced ovarian, primary peritoneal, or fallopian tube cancer

Who Can Participate in the Study?

Adult females with newly diagnosed advance ovarian, primary peritoneal, or fallopian tube cancer

Age Group
Adults

What is Involved?

This study has a pre-screening period that includes testing your tumor tissue for biomarkers.

If you agree to be in this study, you will:

- Be randomized, like drawing numbers out of a hat, to one of three different study drug options, depending on the results of your BRCA genetic testing. These options include the use of a placebo, which is a "sugar pill"; or an intravenous placebo.
- Get up to 6 cycles of standard chemotherapy with or without bevacizumab.
- Get a combination of durvalumab, olaparib, or placebo for up to 15 months.

- Return for follow-up visits after the end of study drug regimen, 30-days post and 90 days post study drug regimen.
- Long-term follow-up contact will be made every 12 weeks for the first 3 years or every 24 weeks after 3 years until the end of participation.

Participation in this study is expected to last up to 6 years and will include 30 or more office visits to the clinic.

Study Details

Full Title
A Phase III Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combination with Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib in Newly Diagnosed Advanced Ovarian Cancer Patients (DUO-O)
Principal Investigator
Gynecologic Oncologist
Protocol Number
IRB: PRO00100372
NCT: NCT03737643
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698